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WO2004110538A1 - Inhalateur de poudre seche et methode pour l'inhalation pulmonaire d'une poudre seche - Google Patents

Inhalateur de poudre seche et methode pour l'inhalation pulmonaire d'une poudre seche Download PDF

Info

Publication number
WO2004110538A1
WO2004110538A1 PCT/NL2004/000427 NL2004000427W WO2004110538A1 WO 2004110538 A1 WO2004110538 A1 WO 2004110538A1 NL 2004000427 W NL2004000427 W NL 2004000427W WO 2004110538 A1 WO2004110538 A1 WO 2004110538A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
dry powder
chambers
inhaler
air
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/NL2004/000427
Other languages
English (en)
Inventor
Anne Haaije De Boer
Paul Hagedoorn
Henderik Willem Frijlink
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rijksuniversiteit Groningen
Original Assignee
Rijksuniversiteit Groningen
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rijksuniversiteit Groningen filed Critical Rijksuniversiteit Groningen
Priority to PL04748659T priority Critical patent/PL1633422T3/pl
Priority to AT04748659T priority patent/ATE437668T1/de
Priority to SI200431271T priority patent/SI1633422T1/sl
Priority to US10/561,410 priority patent/US7617822B2/en
Priority to DE602004022289T priority patent/DE602004022289D1/de
Priority to EP04748659A priority patent/EP1633422B1/fr
Priority to DK04748659T priority patent/DK1633422T3/da
Priority to CN2004800167409A priority patent/CN1805765B/zh
Priority to CA2529069A priority patent/CA2529069C/fr
Priority to JP2006516986A priority patent/JP4646909B2/ja
Publication of WO2004110538A1 publication Critical patent/WO2004110538A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0091Inhalators mechanically breath-triggered
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0003Details of inhalators; Constructional features thereof with means for dispensing more than one drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043Non-destructive separation of the package, e.g. peeling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/16Rotating swirling helical flow, e.g. by tangential inflows

Definitions

  • breath actuated powder inhalers Compared to dry powder inhalers that use an auxiliary power source to de-agglomerate the medicament, these so called breath actuated powder inhalers have the advantage of being independent from an energy source, which advantage can be used to increase reliability and simplicity of the design.
  • the housing may comprise a carrier carrying a plurality of sealed dose compartments, the compartments on the carrier being indexable relative to the supply area of the inhaler.
  • the housing may form a reusable unit or a disposable unit for a plurality of doses.
  • the breath actuated dry powder inhaler comprises at least one further air circulation chamber for de- agglomeration of entrained powdered medicament, the chambers being connected to the mouthpiece in parallel. This way, relatively large doses of medicament can be inhaled in one inhalation, while maintaining low respiratory resistance and high de-agglomeration efficiency.
  • Fig. 9a a top plan view of a disc shaped embodiment of the breath actuated dry powder inhaler, comprising a carrier carrying a plurality of sealed dose compartments, the compartments on the carrier being indexable relative to the supply area of the inhaler;
  • Fig. 9c a top plan view of an intermediate plate for the embodiment of fig. 9a.
  • the inhaler 1 comprises a substantially planar housing 14 having the shape and size of a thick credit card, being constructed as a disposable unit.
  • the chambers 2 are disposed in the housing 14 such that the central axes 4 of the chambers 2 extend transversely to the plane of the housing.
  • the discharge channel 12, 12a is disposed in the housing 14 such that it extends in the plane of the housing.
  • the mouthpiece 13 is provided on a peripheral edge 15 of the housing.
  • the discharge channel 12, 12a and the circulation chambers 2 extend in substantially parallel planes.
  • the mouthpiece 13 discharges an aerosol cloud of de -agglomerated powder particles entrained from the air recirculation chamber 2 in a direction parallel to the longitudinal axis 1 of the inhaler housing, while the axes of both classifying chambers 2 are perpendicular to the longitudinal axis 1 of the inhaler housing 14.
  • the housing 14 (see also fig. 2) is built up of a stack of substantially planar elements 16. These elements 16 include a bottom plate 17, an intermediate plate 18 and a top plate 19. The planar elements are provided with projections 20 and openings 10 that in the stack cooperate to form the flow passages, in particular the chamber 2, the supply channels 7, the supply region 8 and the discharge channels 12, 12a of the inhaler 1.
  • the top surface of the bottom plate 19 e.g. forms the bottom wall 6 of the chambers 2, and carries projections 20 that form the sidewalls 3.
  • the chambers 2 are closed off by the bottom surface of the intermediate plate 18, forming the top walls 5 of the chambers 2.
  • the intermediate plate 18 forms a division between a bottom plane in which the chambers 2 extend and a parallel top plane in which the discharge channel 12 extends. Discharge openings 10 in the intermediate plane 18 form a passage for air and entrained, de-agglomerated medicine particles exiting the chamber through air outlet 9 extending axially along axis
  • FIG. 2 a perspective view of an alternative embodiment of the inhaler of fig. Ia is shown in assembled state with arrows indicating the air flow path.
  • This embodiment contains a carrier 26 carrying three of dose compartments 23, the compartments on the carrier 26 being indexable relative to the supply area 8 of the inhaler 1.
  • Figs. 3 a-h show top plan views of alternative embodiments for a bottom plate 19 for a breath actuated dry powder inhaler 1 having twin parallel circulation chambers 2.
  • the classifier chambers 2 each have three supply channels 7, while figs. 3g and 3h show four supply channels 7.
  • the front supply channels 7 draw air from beneath the bottom plate 19.
  • the air is supplied to the front supply channels 7 over the intermediate plate 18.
  • the air may be supplied through channels extending along the sides of the plate (not shown).
  • the number of channels 7 and their layout influences the air resistance, the speed in the circulation chamber 2, the accumulation of the drug in the chambers 2, the retention time of the particles in the powder and the maximum powder capacity per dose. Generally, the speed will increase if the number of supply channels is increased.
  • the shape of the circulation chambers 2 may be chosen to suit the formulation of the powder, e.g. substantially circular chambers (3a-3e, 3g) for pelletized powder particles and substantially polygonal chambers (3f and 3h) for carriers with adhesive particles.
  • the classifier chambers 2 basically have the shape of a hexagon and an octagon, respectively.
  • the sides of the octagon may have equal or different lengths in order to provide special acceleration sides and impaction plates with which carrier particles collide for effective fine drug particle removal. It is noted that the classifier chambers can have other shapes.
  • the bottom wall 6 and/or top wall 5 of the chamber 2 may be slightly conical or dome-shaped.
  • the shape of the bottom and top wall also influence the retention time and retention efficiency (cut-off efficiency) of the chamber 2.
  • Fig. 7a shows a top plan view of a bottom plate 19 of an alternative embodiment in which the axis through the mouth piece 13 extends at a sharp angle relative to the longitudinal axis 1 of the housing 14.
  • the joint powder channel 7b extends through two supply regions 8, each comprising a blister pocket 23.
  • the housing of this embodiment comprises a central air inlet opening 27 that may be covered with a pull off cover, e.g. a foil.
  • the pull off cover may be integrated with a removable foil 24 of the blister pocket 23.
  • the classifying cambers 2 are arranged side-to-side in the same plane, having different parallel longitudinal axes 4. However, it is also possible to arrange the chambers 2 bottom-to- bottom, sharing the same axis. Also, it is possible to arrange the classifying chambers 2 top-to-top with their discharge holes 10 facing each other, sharing the same axis 4. Such an arrangement is shown in fig. 10. From fig. 10 it will be apparent that the chambers 2 need not be orientated with their axis 4 substantially vertically during use, but may e.g. also be orientated with their axes 4 substantially horizontally or obliquely. Further, the orientation of the classifying chambers need not be the same for all chambers.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un inhalateur de poudre sèche actionné par la respiration (1) comprenant une chambre de circulation d'air sensiblement en forme de disque (2) destinée à la désagglomération d'un médicament en poudre entraîné au moyen de l'énergie du flux d'air d'inspiration. Cette chambre comprend une paroi latérale sensiblement circulaire ou polygonale (3) s'étendant autour d'un axe central (4) entre des parois supérieure (5) et inférieure (6) de la chambre de sorte que la hauteur (h) de la chambre soit plus petite que son diamètre (d). Une pluralité de canaux d'alimentation en air (7) disposés autour de la circonférence de la chambre s'étendent à partir d'entrées d'air jointes ou séparées et entrent dans la chambre de manière sensiblement tangentielle par rapport à sa paroi latérale. L'un au moins des canaux d'alimentation s'étend à travers une zone d'alimentation en dose de poudre (8) de l'inhalateur. La chambre comprend en outre une sortie d'air (9) s'étendant axialement à partir d'une ouverture d'évacuation (10) dans le centre de la paroi supérieure ou inférieure de la chambre, et communique avec un canal d'évacuation (12) s'étendant jusqu'à un embout buccal (13). Cet inhalateur comprend au moins une chambre de circulation d'air supplémentaire destinée à la désagglomération du médicament en poudre entraîné, ces chambres étant reliées à l'embout buccal en parallèle.
PCT/NL2004/000427 2003-06-16 2004-06-16 Inhalateur de poudre seche et methode pour l'inhalation pulmonaire d'une poudre seche Ceased WO2004110538A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
PL04748659T PL1633422T3 (pl) 2003-06-16 2004-06-16 Inhalator proszkowy
AT04748659T ATE437668T1 (de) 2003-06-16 2004-06-16 Trockenpulverinhalator
SI200431271T SI1633422T1 (sl) 2003-06-16 2004-06-16 Suho praškasti inhalator
US10/561,410 US7617822B2 (en) 2003-06-16 2004-06-16 Dry powder inhaler and method for pulmonary inhalation of dry powder
DE602004022289T DE602004022289D1 (de) 2003-06-16 2004-06-16 Trockenpulverinhalator
EP04748659A EP1633422B1 (fr) 2003-06-16 2004-06-16 Inhalateur de poudre seche
DK04748659T DK1633422T3 (da) 2003-06-16 2004-06-16 Törpulverinhalator
CN2004800167409A CN1805765B (zh) 2003-06-16 2004-06-16 干粉吸入器以及干粉的肺吸入方法
CA2529069A CA2529069C (fr) 2003-06-16 2004-06-16 Inhalateur de poudre seche et methode pour l'inhalation pulmonaire d'une poudre seche
JP2006516986A JP4646909B2 (ja) 2003-06-16 2004-06-16 乾燥粉末吸入器および乾燥粉末の肺吸入方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP03076883.2 2003-06-16
EP03076883A EP1488819A1 (fr) 2003-06-16 2003-06-16 Inhalateur de poudre sèche et procédé d'inhalation pulmonaire de poudre sèche

Publications (1)

Publication Number Publication Date
WO2004110538A1 true WO2004110538A1 (fr) 2004-12-23

Family

ID=33395911

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/NL2004/000427 Ceased WO2004110538A1 (fr) 2003-06-16 2004-06-16 Inhalateur de poudre seche et methode pour l'inhalation pulmonaire d'une poudre seche

Country Status (14)

Country Link
US (1) US7617822B2 (fr)
EP (2) EP1488819A1 (fr)
JP (1) JP4646909B2 (fr)
CN (1) CN1805765B (fr)
AT (1) ATE437668T1 (fr)
CA (1) CA2529069C (fr)
CY (1) CY1110523T1 (fr)
DE (1) DE602004022289D1 (fr)
DK (1) DK1633422T3 (fr)
ES (1) ES2331005T3 (fr)
PL (1) PL1633422T3 (fr)
PT (1) PT1633422E (fr)
SI (1) SI1633422T1 (fr)
WO (1) WO2004110538A1 (fr)

Cited By (3)

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EP2082764A1 (fr) * 2008-01-24 2009-07-29 Boehringer Ingelheim International GmbH Inhalateur
US20130203695A1 (en) * 2010-10-29 2013-08-08 Opko Health, Inc. Hypersulfated disaccharides to treat elastase related disorders
EP2944343A1 (fr) 2014-05-15 2015-11-18 AstraZeneca AB Inhalateur de poudre sèche

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CN109821118A (zh) * 2017-11-23 2019-05-31 正大天晴药业集团股份有限公司 新型肺部药物输送系统
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CN120227544A (zh) * 2023-12-29 2025-07-01 传思生物公司 转动机构、剂量保护机构、呼吸触发装置及干粉吸入器

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EP1633422A1 (fr) 2006-03-15
PT1633422E (pt) 2009-11-03
ES2331005T3 (es) 2009-12-18
CA2529069C (fr) 2013-03-12
SI1633422T1 (sl) 2009-12-31
DE602004022289D1 (de) 2009-09-10
JP4646909B2 (ja) 2011-03-09
CY1110523T1 (el) 2015-04-29
PL1633422T3 (pl) 2010-01-29
JP2006527624A (ja) 2006-12-07
DK1633422T3 (da) 2009-12-07
EP1488819A1 (fr) 2004-12-22
CN1805765A (zh) 2006-07-19
CA2529069A1 (fr) 2004-12-23
CN1805765B (zh) 2010-09-29
EP1633422B1 (fr) 2009-07-29
ATE437668T1 (de) 2009-08-15
US7617822B2 (en) 2009-11-17

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